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FDA 510(k)

BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER

K-Number: K880371 · 1988-11-18

ApplicantAmerican Biomaterials Corp.
Decision Date1988-11-18
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER is the device name listed in this FDA 510(k) record. The listed applicant is American Biomaterials Corp.. It received FDA 510(k) clearance on 1988-11-18 under 510(k) number K880371. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER?

BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER is a medical device that received FDA 510(k) clearance on 1988-11-18. The listed applicant is American Biomaterials Corp.. The 510(k) number is K880371.

When did BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER receive FDA 510(k) clearance?

BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER received FDA 510(k) clearance on 1988-11-18, under 510(k) number K880371.

Who is the listed applicant for BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER?

The FDA 510(k) record lists American Biomaterials Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER?

The FDA product code for BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER is LYC.

Related Clinical Trials

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Other records listing American Biomaterials Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K922455EVERT-O-CATH CATHETERK924725AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTSK915824HOLE PUNCHK863796CREATIVE CARE SYSTEMS' IV START KITK843461BIOGLASS OSSICULAR RECONSTRUCTION PROSTH

Related Devices (Code: LYC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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